Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT04889235
Status:
UNKNOWN
Last Update Posted:
2021-05-17
First Post:
2020-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diaphragm Kinetics Following Hepatic Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2020-10-21', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diaphragm kinetics', 'timeFrame': 'Day 1', 'description': 'Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following outcome value.\n\n-Deformation%\n\nMean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Diaphragm kinetics', 'timeFrame': 'Day 1', 'description': 'Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Deformation velocity (in cm/second)\n\nMean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Diaphragm kinetics', 'timeFrame': 'Day 1', 'description': 'Comparing diaphragm kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Fractional thickening (thickening coefficient)\n\nMean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Diaphragm kinetics', 'timeFrame': 'Day 1', 'description': 'Comparing diaphragm and abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Range of DIA (in cm)\n\nMean values and standard deviations of individual values describing diaphragm kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': 'Day 1', 'description': 'Primary outcome:\n\nComparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Thickness (in cm)\n\nMean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': 'Day 1', 'description': 'Primary outcome:\n\nComparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Deformation%\n\nMean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': 'Day 1', 'description': 'Primary outcome:\n\nComparing abdominal muscle kinetics between sarcopenic and non-sarcopenic patients prior to elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Deformation velocity (in cm/second)\n\nMean values and standard deviations of individual values describing abdominal muscle kinetics of sarcopenic and non-sarcopenic groups will be compared. Preoperative values will be used as baseline values for the evaluation of longitudonal changes (secondary outcome measure)'}], 'secondaryOutcomes': [{'measure': 'Diaphragm kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Deformation%\n\nDifferences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Diaphragm kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Deformation velocity (in cm/second)\n\nDifferences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Diaphragm kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Fractional thickening (thickening coefficient)\n\nDifferences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Diaphragm kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in diaphragm kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nDiaphragm muscle kinetics will be evaluated using the following value.\n\n-Range of DIA (in cm)\n\nDifferences in mean values and standard deviations of individual values describing diaphragm muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Thickness (in cm)\n\nDifferences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Deformation%\n\nDifferences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}, {'measure': 'Abdominal muscle kinetics', 'timeFrame': '30 days', 'description': 'Evaluating longitudinal changes in abdominal muscle kinetics in the postoperative phase across sarcopenic and non-sarcopenic groups following elective major hepatic resection using ST ultrasound.\n\nAbdominal muscle kinetics will be evaluated using the following value.\n\n-Deformation velocity (in cm/second)\n\nDifferences in mean values and standard deviations of individual values describing abdominal muscle kinetics will be compared between sarcopenic and non-sarcopenic groups. Changes in diaphragm kinetics will be defined as changes from baseline values (primary outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Kinetics', 'Sarcopenia', 'Muscle Wasting', 'Liver Resection']}, 'descriptionModule': {'briefSummary': 'Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising post-operative pulmonary function.\n\nHypotheses:\n\n* Both major hepatic resection and sarcopenia have a measurable impact on diaphragm function.\n* Sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection.\n\nGoals:\n\nThe primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared to non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared to non-sarcopenic patients.\n\nMethods and analysis:\n\nTrans-costal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in patients undergoing major hepatic resection starting one day prior to surgery and up to thirty days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery (SPPB). A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will entail a prospective observational single center study, analyzing 44 consecutive patients undergoing major liver resection, 22 patients will be sarcopenic, 22 will be non-sarcopenic', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18- and 80 years old\n* Patients undergoing elective Major hepatic resection for the treatment of malignant disease.\n* Patients with all tumor Stages (TNM classification).\n* Only patients undergoing Major hepatic resection.\n\nExclusion Criteria:\n\n* American Anesthesiology Association (ASA)-classification IV or higher\n* Liver cirrhosis Child grade B or higher\n* End stage renal disease requiring dialysis\n* Severe heart disease New York Heart Association class IV\n* Pulmonary condition:\n\n * Chronic obstructive pulmonary disease (COPD)\n * Asthma\n * History of pulmonary surgery\n * History of pulmonary embolism\n * Smoking\n * Pleural effusion occupying more than 1/3 of the pleural space\n* Neurological disorders leading to paraparesis of the upper or lower limbs\n* Known muscular dystrophic disorders'}, 'identificationModule': {'nctId': 'NCT04889235', 'briefTitle': 'Diaphragm Kinetics Following Hepatic Resection', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Diaphragm Kinetics Following Hepatic Resection, Comparison Between a Sarcopenic and Non-sarcopenic Cohort.', 'orgStudyIdInfo': {'id': 'EK 309-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sarcopenia', 'description': 'Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)', 'interventionNames': ['Procedure: Major liver resection']}, {'label': 'No Sarcopenia', 'description': 'Sarcopenia will be defined as either low estimated muscle mass measured by CT-muscle volumetry or reduced muscle function measured by handgrip strength, or reduced physical condition as defined by the European Working Group on Sarcopenia in Older People (EWGSOP)', 'interventionNames': ['Procedure: Major liver resection']}], 'interventions': [{'name': 'Major liver resection', 'type': 'PROCEDURE', 'description': 'All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed', 'armGroupLabels': ['No Sarcopenia', 'Sarcopenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Gregory van der Kroft, M.D.', 'role': 'CONTACT', 'email': 'gvanderkroft@ukaachen.de'}], 'facility': 'Uniklinik Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Gregory van der Kroft, M.D.', 'role': 'CONTACT', 'email': 'gvanderkroft@ukaachen.de', 'phone': '+492418089501'}, {'name': 'Steven Olde Damink, Prof.', 'role': 'CONTACT', 'email': 'steven.oldedamink@maastrichtuniversity.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator. Drs.', 'investigatorFullName': 'Gregory van der Kroft', 'investigatorAffiliation': 'RWTH Aachen University'}}}}